Kornimate/medical-research-clean huggingface dataset:
promoting mental health of teachers and caregiver using a personalized mhealth toolkit in uganda

Conditions: Mental Health Literacy; Depression, Anxiety

Summary: this is a randomized controlled trial with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents), with the aim of pilot testing the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mhealth toolkit for wellness \& empowering lives of school community (mwel) in uganda. the mwel-app is a preventive intervention tool for teachers and parents as a self-help support modality. caregivers who need support in navigating the toolkit will be supported by p-chws. the investigators hypothesize that: 1) relative to the control, caregivers receiving the mwel will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mwel implementation will have high acceptability, appropriateness, and feasibility.


Eligibility criteria:
teachers inclusion criteria: * teaching in recruited schools. * at least 18 years old. parents inclusion criteria: * at least 18 years old. * have a child aged 6-14 years. exclusion criteria: * evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or completing the survey instruments or the focus group of the study. * parents/teachers/caregivers who are not in one of our recruited primary school * participants under the age of 18 * participant who does not speak english and luganda will not be able to participate
an evidence-based approach for bullying prevention

Conditions: Bullying; Cyberbullying; Substance Use; Substance Abuse

Summary: this phase ii sbir project is designed to address the critical public health problem of bullying and cyberbullying among middle school age youth. the project involves developing and testing bullying and cyberbullying prevention materials, including interactive classroom sessions and corresponding serious games, based on the evidence-based substance abuse prevention approach called life skills training. the product has the potential to fill a gap in the intervention tools currently available to schools that can be widely disseminated throughout the country using existing marketing and dissemination channels and decrease the adverse consequences of bullying and cyberbullying as well as substance abuse.


Eligibility criteria:
inclusion criteria: * middle school aged-youth exclusion criteria: * significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
fixed-dose versus concentration-controlled mycophenolate mofetil for the treatment of active lupus nephritis

Conditions: Lupus Nephritis

Summary: a randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.


Eligibility criteria:
inclusion criteria: * age 18-65 year * diagnosis of sle according to acr criteria. at least 4 criteria must have been present for the diagnosis of sle * active lupus nephritis (both new and flare patients can be included) defined as: * within 16 weeks of randomization, had biopsy-proven isn class iii or iv \[exclude iii(c), iv-s(c) and iv-g(c). patients are permitted to have co-existing class v and * at screening day, has urine protein creatinine ratio (upcr) or 24-hour urinary protein ≥ 1.0 g/g or g/day exclusion criteria: * pregnancy or breast feeding * child-bearing age women who refuse to use effective birth-control * poor compliance * estimated-gfr \< 20 ml/min/1.73 m2 * crescentic glomeruli more than 30 percent * severe extra-renal involvement of sle * history of severe allergic reactions or adverse effects to mmf * uncontrolled concomitant disease * known active, clinically significant infection of any kind * history of serious recurrent or chronic infection * history of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured) * concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening * treatment with more than 1 g cyclophosphamide within the past 24 weeks * receipt more than 3 g of iv pulse methylprednisolone within the past 12 weeks * receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks * treatment with mmf at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks * on treatment with tacrolimus or cyclosporine on the day of screening * treatment with any biologic b-cell depleting therapy (e.g. anti cd-20, anti cd 22) within 52 weeks * receiving concomitant medication interfering pk of mpa * cholestyramine * rifampin
dianeal, extraneal, nutrineal (d-e-n) versus dianeal only in diabetic continuous ambulatory peritoneal dialysis (capd) patients

Conditions: End Stage Renal Disease (ESRD); Diabetes; CAPD

Summary: primary objective: to demonstrate that use of glucose sparing prescriptions, dianeal, extraneal, nutrineal (d-e-n) versus dianeal only, in diabetic (type 1 and type 2) continuous ambulatory peritoneal dialysis (capd) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the hba1c levels. secondary objectives: to demonstrate that use of glucose-sparing peritoneal dialysis solutions (d-e-n versus dianeal only) in diabetic (type 1 and type 2) capd patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and quality of life.


Eligibility criteria:
inclusion criteria: 1. male or female patients 18 years of age or older 2. diagnosis of esrd \[glomerular filtration rate (gfr) ≤ 15 ml/min\] 3. capd using only dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time 4. diabetes mellitus (type 1 and 2) 5. hba1c \> 6.0% but ≤ 12.0% 6. blood hemoglobin ≥ 8.0 g/dl, but ≤ 13.0 g/dl 7. total kt/v ≥ 1.7 exclusion criteria: 1. blood urea nitrogen (bun) \> 95 mg/dl 2. exposure to extraneal within 60 days of screening 3. mean arterial pressure (map) ≥ 125 mm hg, or volume depleted (map \< 77mm hg) at screening 4. peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days 5. cardiovascular event within the last 30 days 6. ongoing clinically significant congestive heart failure \[new york heart association (nyha) class iii or iv\] 7. allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance 8. receiving rosiglitazone maleate

Keywords: esrd diabetes capd
opioid free vs opioid based anesthesia for laparoscopic sleeve gastrectomy

Conditions: Obesity; Postoperative Pain; Postoperative Nausea; Postoperative Vomiting; Opioid Use

Summary: opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

the study has been approved by bioethical committee of medical university of warsaw. informed written consent will be obtained from all patients. sample size of 60 patients has been calculated based on the altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%. consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia. opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil tci minto model. after the end of operation all of the patient will receive oxycodone and additional doses via pca system for postoperative analgesia.

Eligibility criteria:
inclusion criteria: * sleeve gastrectomy in patients with bmi \> 40 or \>35 with comorbidities * written informed consent exclusion criteria: * patient's refusal * known allergies to study medication * inability to comprehend or participate in pain scoring scale * inability to use intravenous patient controlled analgesia * changes of operation extent during procedure * revisional operations

Keywords: opioid free anesthesia laparoscopic sleeve gastrectomy
impact of blood glucose at the first trimester of pregnant women with gestational diabetes on maternal and fetal outcomes and metabolic disorders: a multi-central prospective cohort study

Conditions: Gestational Diabetes

Summary: the study is to investigate the impact of blood glucose management at the first trimester of pregnant women with gestational diabetes on the maternal and fetal outcomes and metabolic disorder.

gestational diabetes(gdm) is the glucose metabolic disorder that first diagnosed during pregnancy. with the development of social economy and the improvement of life, the incidence of gdm increases to a level of 18-20% year by year. high blood glucose has a strong relationship with many adverse maternal and fetal outcomes, but also influences their metabolism including the increase of susceptibility of maternal type 2 diabetes and risk of fetal type 2 diabetes, obesity, coronary heart disease, etc. and therefore, it is significant to screening and managing maternal blood glucose to prevent maternal and fetal adverse outcomes and metabolic disorder. this multi-central prospective cohort study is supposed to study the pregnant women whose fasting blood glucose is slightly increased (between 5.1 mmol/l and 7.0 mmol/l) at the first gestational trimester. the aim of this study is to answer the scientific questions bellow: whether interventions to whom the blood glucose is slightly increased can 1. decrease the incidence of gdm at the second gestational trimester; 2. improve gestational outcomes; 3. decrease the incidence of temporal and distant metabolic disorder of mother and her child. the result will provide scientific evidence for improving the gestational outcomes of gdm women and preventing metabolic disorder of their child during adolescence and adult period.

Eligibility criteria:
inclusion criteria: * regular antenatal examination from the first trimester; * accurate left mentoposterior(lmp) verified by ultrasonography(usg); * fasting blood glucose level between 5.1 mmol/l and 7.0 mmol/l. exclusion criteria: * younger than 18 years old; * do not give birth in the research centers above; * lmp is undefined and lack of usg during 6-14 gestational weeks; * multiple pregnancy; * non-natural pregnancy(including intrauterine insemination(iui), in-vitro fertilization and embryo transfer(ivf-et), etc); * diagnosed dm before pregnancy; * with hepatitis b virus, hepatitis c virus, hiv infection; * taking drugs including glucocorticoid, diuretic, angiotensin-converting enzyme inhibitor/angiotensin ii receptor blocker(acei/arb), etc. * complicated with diseases that affect glucose metabolism such as hyperthyroidism and so on.
study evaluating mitoxantrone in multiple sclerosis

Conditions: Secondary Progressive Multiple Sclerosis

Summary: the purpose of this study is to show the dose-response relationship of three doses of mitoxantrone with regard to efficacy in patients with secondary progressive multiple sclerosis and to show the safety and tolerability of mitoxantrone in these patients.


Eligibility criteria:
inclusion criteria: * secondary progressive ms in an active stage * edss between 3 and 6 exclusion criteria: * benign or primary progressive ms * patients with cardiac risk factors * patients who have already received mitoxantrone

Keywords: multiple sclerosis
pk tdf in thai hiv-infected children

Conditions: HIV

Summary: this study will assess the pharmacokinetics of tdf in thai hiv-infected children

hiv-infected children who are currently on tdf-base once daily regimen will be enrolled into this study. pk visit will be performed at least 1 month after changing regimen to once daily regimen. adherence 3 days before pk study will be confirmed using adherence questionnaire. 100% of adherence is needed for pk study. if there is adherence problem on pk visit, pk study will be deferred to at least 3 days. on pk visit, blood drawn will be performed at 0, 2, 4, 6, 8, 10, 12, 24 hr. after taking arvs for pk study. blood drawn for safety evaluation will be drawn at any time-point on the pk visit. there is no study drug in this study. all arvs that patient taking will be according to patient's requirement, and physician judgment. arvs dosage will follow the thai national pediatric guideline. cbc, cd4, viral rna, viral resistance, alt, cholesterol, and triglyceride results can be from other visits within 4 weeks window period. statistical considerations sample size calculations. there are no pharmacokinetic data in children. in adults, the mean (sd) auc following administration of a 300mg viread tablet in fasting state is 2.29 (0.69) microg.hr/ml. in patients taking lopinavir/ritonavir and atazanavir/ritonavir, the mean auc of tdf is increased by 32% and 24% respectively. efavirenz does not change the auc of tdf. if the weight adjusted dose of tdf in children and adolescents achieves the same auc as in adults and concomitant dosing with a protease inhibitor increases the tdf auc by 30% but concomitant dosing with efavirenz does not change the tdf auc, then 20 treated with efavirenz and 20 patients treated on a pi based regimen would provide 90% power to detect this difference at the 5% significance level. statistical analysis. primary endpoints pharmacokinetic parameters will be calculated based on individual plasma concentration vs time data, using noncompartmental methods. data will be summarized overall and by whether the patient is taking a pi or an efv-based regimen. formal statistical comparisons of parameters will be made using anova techniques or non-parametric equivalents as appropriate. effect sizes and 95% confidence intervals will be given for all comparisons.

Eligibility criteria:
inclusion criteria: * children between the ages of 8-18 years with documented hiv infection * currently on tdf once daily regimen * have signed the informed consent exclusion criteria: * the child or care taker refuse to participate in the study * severity of adverse events is more than grade 3 thirty days before participating in the study

Keywords: pharmacokinetics tdf hiv-infected children thai non-nucleoside reverse transcriptase inhibitor (nnrti) ritonavir-boosted protease inhibitor (bpi) less than eighteen years old
efficacy and safety of ac102 compared to steroids in adults with idiopathic sudden sensorineural hearing loss (issnhl)

Conditions: Hearing Loss, Sensorineural

Summary: the purpose of this phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of ac102 administered as single intratympanic injection compared to oral steroid treatment in patients with idiopathic sudden sensorineural hearing loss (issnhl).


Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 and 85 years * unilateral issnhl * onset of unilateral issnhl between 24 to 120 hours prior to randomization * an absolute air conduction hearing threshold of at least 65 db, * patients with a relative hearing loss of at least 30 db compared to the current audiogram of the non-affected ear exclusion criteria: * insufficient handling of the language used in the speech audiometry tests * bilateral hearing loss * acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time * congenital hearing loss * conductive hearing loss or combined hearing loss determined by a 4pta \> 10 db * history of issnhl in the past 1 years in the affected ear

Keywords: hearing loss hearing impairment hearing loss, sensorineural ear diseases otorhinolaryngologic diseases hearing loss, unilateral intratympanic administration restoration of hearing loss
effects of transcutaneous electrical nerve stimulation on spasticity in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is a group of mental disorder that disrupts the person's ability of moving, maintaining their balance and posture. cerebral palsy is a motor disorganization in childhood. cerebral palsy can occur before birth, during birth, within a month after birth, or during 1st year of life when brain is under development. symptoms vary from person to person in case of severe cp child must needs the equipment used to enhance their mobility and to train muscles. transcutaneous electrical nerve stimulation (tens) is method of relieving pain by using mild electric current. purpose of this study will be to determine effects of tens on spasticity and gross motor function in children with cerebral palsy. tens is a small machine operated with battery containing attached sticky pads known as electrodes placed on stiffed and painful area of muscles. classified by ashworth scale and modified tardieu scale. subjects will be randomly divided into four groups 1) group a= tens on spastic muscle/agonist, 2) group b= tens on antagonist, 3) groupc= tens on both agonist and antagonist muscle, group d= conventional physiotherapy total treatment period is about 3 to 6 weeks. this study will help to discuss how much extent tens will effect spasticity in children with cerebral palsy. data will be analyzed through spss 22


Eligibility criteria:
inclusion criteria: * age 6-12 * both male and female * spastic cerebral palsy exclusion criteria: * patients with history of uncontrolled seizures * patients undergoing previous tendon lengthening surgery * history of botox injection
prostaglandins before caserean section

Conditions: Intrapartum Hemorrhage

Summary: the aim of our study is to assess the value of administration of prostaglandins before cesarean section to reduce the amount of blood loss

160 full term pregnant patients candidate for elective cesarean section were randomly allocated into 2 groups ,80 patients will receive 200mcg of rectal prostaglandins before cesarean section and 80 patients are used as control receiving placebo

Eligibility criteria:
inclusion criteria:pregnant patients full term elective cesarean section - exclusion criteria: * medical disorder with pregnancy
the short-term impact of vocal intonation therapy (vit) and therapeutic singing (ts) on respiratory function in patients with lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to examine the short-term impact of vocal intonation therapy (vit) and therapeutic singing (ts) on respiratory function in patients with lung cancer. as a secondary outcome, this research will evaluate the effect of the music intervention on respiratory quality of life.


Eligibility criteria:
inclusion criteria: * participants will include three patients diagnosed with lung cancer, stages i-iii, who have undergone a thoracentesis or thoracotomy in the last 12 months. thoracic surgical procedures include pulmonary lobectomy or cancer-related surgical procedure (e.g., pneumonectomy). this diagnosis must be made by the patient's oncologist and medical team. * the age range will be 40 to 80 years old. both female and male participants from any race and ethnicity will be included in the study. * the study will include english and spanish speakers only. * patients must have less than five years of voice training experience (e.g., choir, private voice lessons). exclusion criteria: * patients in respiratory failure * individuals with severe neurological and hearing impairments. * patients with diagnosed dysphonia and individuals who have undergone a laryngectomy * participants that do not have access to an electronic device, either an ipad, tablet, or laptop, as well as reliable internet access. they will also need to have adequate knowledge of technology or participate with a caregiver who knows how to navigate zoom. * participants who do not have access to a quiet space. headphones are optional for this study. * prisoners * persons under the age of 40 or over the age of 80.
ketamine sedation in mechanically ventilated patients

Conditions: Respiratory Insufficiency; Pain; Psychomotor Agitation

Summary: * adequate sedation is of paramount importance to avoid stress and pain in mechanically ventilated patients. it is usually achieved by infusing sedatives (benzodiazepine) and analgesic (opiate) drugs. * this combined sedation may not be sufficient in some instances. * the aim of this study is to evaluate whether addition of a third substance, ketamine, allows the achievement of better sedation and avoids the use of neuromuscular blocking agents.

* mechanical ventilation is widely used in critically ill patients. sedation is used in most instances to alleviate symptoms of pain and distress. it usually consists of an association of opiates and benzodiazepines. * in some instances, pain and agitation persist despite this combined sedation regimen. in such cases, the clinicians have the choice between increasing dosage of these 2 substances which may increase their adverse effects (mainly hypotension) and/or adding a neuromuscular blocking agent which is not devoid of adverse effects (mainly the onset of neuromyopathy of critical illness). * this study will assess the safety, efficacy and cost-effectiveness of adding ketamine, a well known anesthetic agent, to a combination of midazolam and sufentanil when this combination is not sufficient to reach acceptable sedation target.

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients who receive adequate dosing of sedative agents (midazolam \> 0.15 mg/kg/h plus sufentanil \> 0.3 mcg/kg/h) * persistence of agitation indicating that sedation is not appropriate, as assessed by validated sedation scales (harris scare; motor activity assessment scale). exclusion criteria: * pregnancy * patient who already receives neuromuscular blocking agents

Keywords: mechanical ventilation agitation